Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02045199

Enrollment

193

Registered

2014-01-24

Start date

2014-02-28

Completion date

2015-03-31

Last updated

2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Cracked Heel in Diabetic Patients With Polyneuropathy

Keywords

Diabetic Neuropathies, Diabetes Mellitus, Diabetic Foot, Diabetes Complications

Brief summary

The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.

Interventions

DEVICETested product : V0111 cream

Application twice a day during 28 days

DEVICEPlacebo

Application twice a day during 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Diabetes mellitus with neuropathy, * Cracked open heel with at least one fissure Grade 2,

Exclusion criteria

* Open wound, skin infection, haemorrhagic crack on feet, * Major static disorder , * Ulceration and history of ulceration, * Active haemorrhagic crack, * Hyperkeratotic disease * Diabetic arteriopathy,

Design outcomes

Primary

Measure	Time frame	Description
Complete healing of target fissure on the heel	Day 28	Comparison of the two treatment groups (verum versus placebo)

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026